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Safe and Effective, Really?


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-06-01-2011
Volume 0
Issue 0

To decide on a course of treatment, patients need to be told the truth straight up

A neighbor of mine recently was told by his GP not to treat his elevated cholesterol with medicines because "all of those drugs have side effects, you know." Instead, he was advised to try more exercise and to eat yogurt. After I had persuaded his wife to construct a sentence for the GP containing the words, "negligence," "disciplinary body," and "compensation," my neighbor got his medicine and his series of appointments with a dietician. His cholesterol is now lower than mine. His GP is still muttering about the benefits of fermented dairy products.


The GP has a point, of course: No completely safe treatment is an option (although statins may be as close as we'll ever get, and more people probably get sick from rancid yogurt than the side effects of statins). The GP's mistake was in thinking that doing nothing was safe.

Those of us who work in pharma policy, advocacy, and marketing conspire in a series of half-truths that cause suffering to patients; confusion among ordinary doctors; and losses to our employers.

Read the central half-truth in every press release about licensing: "the FDA has determined ... to be safe and effective in..." Maybe—back when Time magazine had a raison d'etre and research required libraries—maybe there was a reason for this false certainty. Those times are long gone. If we don't become more truthful, the Internet age will leave us looking not just discredited but silly as well.

Doing Nothing.

It is imperative to be more aggressive about the dangers of not treating and preventing. Doing nothing is often high risk as my neighbor might have found out had he just eaten his yogurt as he was told to.

"Do you want us to tell people that their doctors are putting their health at risk?" a client wailed once.

Absolutely: if doctors are failing to diagnose and treat properly, tell the truth. For example, someone should say, "If you are a man over 50 and you have never had a rectal digital exam, your doctor is putting your life at risk."

The result will be lives saved and an increased number of effective treatment courses for prostate cancer. It will upset primary care physicians (who don't like doing the exams and, anyway, resent the intrusion on golfing time by a diagnostic that they can't charge for), but you shouldn't worry too much.

Our company almost persuaded the European head of a major pharma company to run an ad in the German press with his picture and the legend, "I may know how to cut your risk of a fracture by 85 percent but I'll be prosecuted if I tell you about it. (What's worse, most of you at high risk have never even been tested to see if you can be helped. I'm not allowed to tell you about that either.)"

The ad went on to talk about bisphosphonates and their impact in reducing fractures among women with osteoporosis. It ended with displaying my client's address in case he was wanted for questioning. Of course, special problems with DTC promotion exist in Europe, but the clients were not most worried about their boss spending the night in jail for violating DTC rules, they were worried about upsetting doctors. Doctors (male doctors especially) tend to think that little old ladies should not complain so much about shrinking. We listen to doctors too much.

The truth has to start being told: life is risky and medical intervention can often cut the risks or at least exchange nasty risks for less nasty ones. Patients need to know about it. It's nothing to apologize for.

More Push, Less Nudge.

Ignoring medical science isn't a legitimate choice. Doctors and their patients need to think about risk in a way that benefits the rest of us. In pharma, we have become conditioned to saying that we are not trying to push people into using medicines. In part, this is because risk is brushed under the carpet So it goes: If individuals are not asked to make decisions about their own risk, we have to go softly when they make decisions that put others at risk. Instead, we should be telling the truth and pushing.

The most shocking of our collective embrace of the "softy, softly" lie is immunization. Last year, official notices in Yiddish cropped up all over New York and New Jersey. Hasidic Jews in the US were the innocent victims of negligence and irresponsibility in Europe. The Hasidim have vaccination rates that are very respectable, but, of course, no vaccine is 100 percent effective. Because of this, the MMR vaccine needs about 85 percent of children in a community to be covered to be sure that no mumps outbreaks will occur. The Hasidim were just below that and are very sociable. A Hasidic child went to Europe on a family visit and came home with mumps. Soon there were thousands of cases all over the tristate area.

Everyone made the right noises about emergency vaccination and a quick public health response. But...

  • Where were the disciplinary hearings for doctors who had left children vulnerable to a deadly disease?

  • Where was the tearful on-screen apology and subsequent mandatory trip to a rehab clinic from the distraught editor of The Lancet, a weekly peer-reviewed general medical journal, one of the oldest and most respected? (It had published the fraudulent "research" that originally cast doubt over the safety of the MMR vaccine—a conspiracy that it later transpired was funded by lawyers fishing for evidence against pharma companies.)

  • Where were the TV interviews on the doorsteps of the Swiss parents responsible for this public health crisis in America? (All over Europe, immunization rates have dropped—sometimes as low as 60 percent.)

A Midwestern couple have become vocal advocates of immunization after they and their chiropractor had decided to leave the couple's child unprotected. The child subsequently contracted and miraculously survived a Hib infection unscathed, and the parents saw the error of their ways. If they had become road safety advocates after letting their child play on 1-95, they would be on probation—at least. It's time to get tough on medicine deniers.

As the Hasidim found out to their cost, individual decisions have community repercussions. And yet, we do almost nothing to push individuals into acting in the community interest on medicine despite the move to the "nudge society" generally. Professor Richard Thaler, an economist at The University of Chicago and the father of Nudge theory (nudges.org), writes about everything from selling ice creams to stopping global warming, but if he has written about encouraging socially responsible behavior in medicine, I've missed it.

Because of the impact on herd immunity, vaccines are the obvious example of reckless individuals endangering the rest of us. But identifying and shaming also could extend into misuse of antibiotics, or even tolerance of childhood obesity.

The theories of making it easier to do the right thing mean that those who refuse to treat heart disease (thus running up future bills that the rest of us have to pay, directly or indirectly) and those who fail to prevent infections should find life more complicated.

No "safe" treatments.

The whole truth about medicine safety needs to be told: just as no trip to the mall is completely safe, neither is any treatment. Most medicines licensed for sale are, though, much safer than going to the mall, especially to the food court.

Safety is often talked about in a way that worked in the 1950s: "people better educated than you know what you should do. Do it." This may still work well for simple things and unlettered people. For example, in my village (in an old industrial area with very poor levels of educational achievement), we have great immunization coverage precisely because most of my neighbors lack the skills to argue with the doctor. This top-down route also helps improve reported compliance amongst the elderly (although a Stanford study of the medicine cabinets of the recently deceased suggests that it may do rather less to improve actual compliance).

The doctor-in-the-white-coat-knows-best approach doesn't, however, work for the Google generation or as medicine becomes more about choices than answers. There is a wide variation between patients in how they respond to disease: Psychologists sometimes speak about repressers and sensitizers. The repressers want to pretend it is not happening while the sensitizers want to know everything. In the Internet age, the repressers find online quacks while the sensitizers find Wikipedia.

This approach stops us from requiring both groups to treat risk as grown-ups. Pharma companies are forced to use tortuous legally acceptable language saying that products are "safe." The opponents of pharma and the lawyers who often fund them have far snappier language to talk about products being "evidently dangerous." Let's forget for a moment the Avandias and Vioxxes of the world: this tussle goes on with a vast range of products from proton pump inhibitors to skin creams. Consumers look at mystifying lists of reported adverse events for every advertised drug and try to decide whether common flatulence is better than rare headaches. GPs see the news story of the month and bounce from prescribing NSAIDs for acute pain (which seem to raise the stroke risk) to opiates (which seem to be creating a new cadre of middle-class addicts) to acetaminophen (which is lethal and disabling in remarkably low levels of overdose).

This is just the rehearsal. If you could hire Lao Tze as a management consultant, he would tell you to forget the journey starting with one step and get walking. As medicine becomes more personal and more focused on prevention, the need to develop individual responsibility for risk decisions will grow.

Elsewhere in this section advertising gurus talk about how they would approach a vaccine that could stop any recipient from enjoying nicotine. Several are in trials. The chances are that all will have rare adverse events. How rare? Well, I guarantee that the risks of any harm will be much, much lower than the risk of smokers getting lung cancer.

Many of those who have sabotaged the effort to protect adolescent girls from cervical cancer (by using HPV vaccines) will, no doubt, see an anti-nicotine vaccine for teenagers as an even greater opportunity to decry the designs of pharma.

An unlikely coalition of conservative and radical groups has already persuaded many US parents to abandon routine infant circumcision even though we know that circumcision will protect their boys from threats as diverse as HIV (circumcised men are probably at a 60% lower risk of contracting HIV through heterosexual sex) and penile cancer.

There will be other vaccines that states and insurers are unlikely to fund for most of us: a vaccine to reduce the risk of nosocomial infection should we be rushed to a hospital, for example (insurers probably will pay for it in some people with scheduled hospital stays), or a vaccine to reduce the likelihood of TB infection (which is very low for people in the industrialized world but which many of us who often sit in airplanes would like to reduce still further). If pharma is selling these vaccines unreimbursed, it will need a way of engaging in a quite sophisticated discussion about the risks that the patient is paying to avoid and the tiny risks that the patient may be incurring in reducing the likelihood of MRSA or TB. It cannot expect GPs or pharmacists to do the hard work on its behalf.

Dr. Paul Janssen, one of the towering figures of the pharma industry in the twentieth century, once proclaimed that his genes protected him from his 60-a-day cigarette habit. On that occasion, he was probably just deluded and lucky (he was rarely deluded but often lucky). In the future, though, more and more will be known about our individual genetic profiles, and about the diseases that threaten us as individuals more than others. Insurers and governments will make some tough health-economic decisions about which to pay for; we are all likely to want to make different decisions for ourselves. After all, a 15 percent reduction in the risk of developing breast cancer may not seem a worthwhile investment for a politician balancing this year's books or an insurance CEO reporting to the market on this quarter; it might look like a good deal, however, to a woman planning on another 60 years in the same body.

Some European governments and a recent article in The NY Review of Books are tut-tutting over how much government spending was "wasted" on stockpiling vaccines and drugs against H1N1. I wasn't eligible for a free vaccine, but I think that the $101 paid for one was one of my best bargains of 2010. And I still carry my Tamiflu around—even if the reports about hallucinations are accurate, I'd prefer a few hours of confusion to life-threatening pneumonia.

Accessing Options.

What we know changes over time but panicking over what was published last week is a bad way of assessing options for yourself or your patients.

Now that medical magazines are under almost as much pressure as other publishers to get eyeballs to their websites and more readers for each copy, even the New England Journal of Medicine and the British Medical Journal are starting to look a bit lurid (or, at least, their press releases are). As every tabloid knows, bad news sells more than good news. Sometimes this shock-of-the-week syndrome works for one company or another—usually, though, because a competitor has had a hit from a "gotcha" article. Despite the occasional benefit, the whole process further undermines the credibility of clinical trials, published data, and industry.

Looking to Vaccines.

Again, vaccines have shown us, in a stark way, how the process goes wrong. News outlets feel obliged to report "both sides of the story," even if one side consists of a deranged naturopath selling herbal enemas while everyone qualified is on the other side. To the casual reader, this looks like a split in opinion. When it is not just the naturopath on the other side but a minority of doctors, things get even more confusing. Journalists will not easily abandon what they have been taught about balance, even if they are trying to balance a whale and a goldfish.

Instead, industry, and government— maybe even the professional associations—need to find a way for journalists to give instant, reliable context alongside the reporting of both sides of the story. This is easy to achieve with online panels, as any political reporter will tell you. Did President Obama's speech on the deficit sway opinion or make a deal more likely? CNN had the answer by the time the President had finished speaking. Will this week's Lancet publication affect how specialists use the medicine in question? We should have credible answers before the journalists finish writing their pieces. If the answer is that 95 percent of specialists probably or certainly will not let the data affect their use or recommendation, panic is much less likely to arise. We could use a variant of the same system to look at the cumulative impact of successive studies.

If pharma does not get ready for these discussions now, a generation's worth of progress could be lost in denial, bashful-ness, and risk exaggeration.

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